Daiichi Sankyo Submits Application for Marketing Approval of
mRNA COVID-19 Vaccine (DS-5670) in Japan

January 13, 2023

Tokyo, Japan – (January 13, 2023) – Daiichi Sankyo (TSE: 4568) today announced the submission of an application for marketing approval of DS-5670 to the regulatory authorities in Japan. DS-5670 is an mRNA vaccine, being developed against the novel coronavirus infectious disease (COVID-19) and is proposed to be used as a booster vaccine for the prevention of COVID-19.

The application is based on results of a phase 1/2/3 trial (original strain) in approximately 5,000 healthy adult and elderly subjects, who received the primary series (two doses) of an mRNA vaccine approved in Japan.

Daiichi Sankyo started prior assessment consultations for drugs with the Pharmaceuticals and Medical Devices Agency in September 2022 based on non-clinical, clinical, and quality data available up to now to obtain marketing approval at an earlier date.

In addition, Daiichi Sankyo plans to move forward with the development of DS-5670 for the Omicron strain in order to respond to new variants of the coronavirus, which continue to mutate, in parallel with the development for the original strain.

Daiichi Sankyo is striving to establish mRNA-vaccine-related technologies and the production and supply system in Japan to ensure a prompt provision of vaccines in the event of outbreaks of emerging and reemerging infectious diseases, thereby contributing to protect safety and security in society and people’s health.

About DS-5670

DS-5670 is an mRNA vaccine against COVID-19 using a novel nucleic acid delivery technology discovered by Daiichi Sankyo, designed to produce antibodies against the receptor binding domain (RBD) of the spike protein of the novel coronavirus, and thus expected to have safety and desirable prevention against COVID19. Furthermore, Daiichi Sankyo is aiming for mRNA vaccines that can be distributed in the refrigerated temperature range (2-8°C).

The clinical development of DS-5670 is being conducted through the “Vaccine development project” promoted by the Japan Agency for Medical Research and Development and the “Urgent improvement project for vaccine manufacturing systems” supported by the Japanese Ministry of Health, Labour and Welfare.

About Daiichi Sankyo

aiichi Sankyo is dedicated to creating new modalities and innovative medicines by leveraging our worldclass science and technology for our purpose “to contribute to the enrichment of quality of life around the world.” In addition to our current portfolio of medicines for cancer and cardiovascular disease, Daiichi Sankyo is primarily focused on developing novel therapies for people with cancer as well as other diseases with high unmet medical need. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation to realize our 2030 Vision to become an “Innovative Global Healthcare Company Contributing to the Sustainable Development of Society.” For more information, please visit www.daiichisankyo.com.

New Drug Application of Ensitrelvir Fumaric Acid, a Therapeutic Drug for COVID-19 Accepted for Review in South Korea

January 4, 2023

OSAKA, Japan, January, 4, 2023 – OSAKA, Japan, January, 4, 2023 – Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D., hereafter “Shionogi”) announced that its partner Ildong Pharmaceutical Co., Ltd. (Head Office: Seoul, South Korea; Vice Chairman and Chief Executive Officer: Yun Paul Woongsup, hereafter “Ildong”) who has been sub-Licensed South Korean rights to Ensitrelvir Fumaric Acid (development number: S-217622, hereafter “ensitrelvir”), has filed a New Drug Application (NDA) with the MFDS (Ministry of Food and Drug Safety) for the indication of SARS-CoV-2 infection, and this application has been accepted for review by MFDS.

Following the approval of ensitrelvir in Japan on November 22, 20221, which was based on the data from the Asian Phase 2/3 clinical trials that SHIONOGI have been conducting, mainly in Japan, Ildong has been in discussions with the MFDS and the Korean Disease Control and Prevention Agency (KDCA) in order to obtain approval in South Korea2. Accordingly, Ildong has now submitted a conditional approval application to MFDS on January 3, 2023, which was accepted for review. Shionogi group will continue to work closely with Ildong to provide the necessary support for approval and commercial launch in South Korea.

Shionogi is committed to “Protect people worldwide from the threat of infectious diseases” as our key focus. We are not only conducting research and development of novel therapeutics, but we are also working towards total care for infectious diseases, through building awareness, epidemiologic monitoring, prevention, diagnosis, and addressing exacerbations, as well as treating the infection itself. As SARS-CoV-2 continues to have a major impact on people’s lives and to represent a global threat, we will seek to contribute to re-establishing the safety and security of society by developing new products and services to address this pandemic. We will continue to pursue global registration, including working with the Medicines Patent Pool to provide access to low- and middle-income countries (LMICs), and to expand and strengthen our manufacturing and global supply chain, in parallel with accumulating additional evidence on efficacy and safety.

About Ensitrelvir Fumaric Acid

Ensitrelvir (Code No.: S-217622), an antiviral drug for COVID-19 currently approved under the emergency regulatory approval system in Japan, is a 3CL protease inhibitor created through joint research between Hokkaido University and Shionogi. SARS-CoV-2 has an enzyme called 3CL protease, which is essential for the replication of the virus. Ensitrelvir suppresses the replication of SARS-CoV-2 by selectively inhibiting 3CL protease. Ensitrelvir is the first antiviral agent to show both clinical symptomatic efficacy for five typical Omicron-related symptoms (primary endpoint) and antiviral efficacy (key secondary endpoint) in patients with mild to moderate SARS-CoV-2 infection, regardless of risk factors or vaccination status, in the Phase 3 part of the Phase 2/3 study conducted during the Omicron-dominant phase of the epidemic 3. Currently, the Phase 2b/3 part of the Phase 2/3 study targeting SARS-CoV-2 infected persons with asymptomatic/mild symptoms only is being conducted in Asia, mainly in Japan. With regard to safety, ensitrelvir was well tolerated, and there were no treatment-related serious adverse events or deaths in the study. The most common treatment-related adverse events were transient decreases in high-density lipoprotein and increases in blood triglycerides, as observed in previous studies. A global Phase 3 trial (SCORPIO-HR study 4 ) in non-hospitalized SARS-CoV-2 infected patients is ongoing. In addition, a global Phase 3 trial (STRIVE study 5 ) for hospitalized SARS-CoV-2 infected patients is scheduled to initiate soon. An onset prevention study for household members living with SARS-CoV-2 infected individuals and a pediatric study for children under the age of 12 are also in preparation.

Chugai’s Actemra Approved for Additional Indication of SARS-CoV-2 Pneumonia in Japan

Jan 21, 2022

The approval is based on the results of several clinical studies in hospitalized patients with COVID-19.

TOKYO, January 21, 2022 — Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that it obtained regulatory approval from the Ministry of Health, Labour and Welfare for the humanized anti-human IL-6 receptor monoclonal antibody, “Actemra® Intravenous Infusion 80 mg, 200 mg, and 400 mg” [generic name: tocilizumab (genetical recombination)] for the additional indication of the treatment of SARS-CoV-2 pneumonia (limited to patients requiring oxygen intervention). The approval came one month after the application for the additional indication on December 13, 2021.

“We are very pleased that Actemra, created by Chugai, has become a new treatment option for SARS-CoV-2 pneumonia. Clinical studies demonstrated that Actemra reduced the mortality rate in patients with SARS-CoV-2 infection,” said Chugai’s President and CEO, Dr. Osamu Okuda. “With the rapid spread of SARS-CoV-2 infection caused by Omicron strain, an increase is expected in the number of patients who become severely ill and develop pneumonia requiring oxygen intervention. We hope that Actemra will play a role for the better prognosis of patients with severe, potentially life-threating pneumonia.”

This approval is based on the results from clinical studies evaluating Actemra in hospitalized patients, including an investigator-initiated, randomized, open-label, platform overseas study (RECOVERY study), three placebo-controlled, randomized, double-blind, multicenter global phase III studies conducted by Roche (COVACTA study, EMPACTA study, REMDACTA study), and a single-arm, multicenter phase III study in Japan (J-COVACTA study).

Actemra has been approved in the European Union, authorized for emergency use in the United States, and recommended by the World Health Organization for the treatment of COVID-19.

Package insert information *excerpt of revised part

Indications: SARS-CoV-2 pneumonia (limited to patients requiring oxygen intervention)

Dosage and administration: The usual adult dosage is a single intravenous infusion of 8 mg/kg tocilizumab (genetic recombination), in combination with corticosteroids. If symptoms do not improve, an additional single dose of 8 mg/kg tocilizumab (genetic recombination) may be administered 8 hours or more after the end of the initial administration.

About Actemra

Actemra is the first therapeutic antibody created in Japan by Chugai. It is designed to block the activity of IL-6, a type of inflammatory cytokine. First launched in June, 2005, the intravenous injection is approved for six indications in Japan: Castleman’s disease, rheumatoid arthritis, systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, cytokine release syndrome induced by tumor-specific T cell infusion therapy, and adult Still’s disease. In addition, Actemra subcutaneous injection is approved for three indications in Japan: rheumatoid arthritis, Takayasu arteritis, giant cell arteritis. Actemra has obtained regulatory approval in more than 110 countries worldwide.